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Randomized Controlled Trial
. 2011 Apr;40(3):255-64.
doi: 10.1016/j.jsat.2010.11.010. Epub 2011 Jan 26.

A randomized controlled trial of fluoxetine in the treatment of cocaine dependence among methadone-maintained patients

Affiliations
Randomized Controlled Trial

A randomized controlled trial of fluoxetine in the treatment of cocaine dependence among methadone-maintained patients

Erin L Winstanley et al. J Subst Abuse Treat. 2011 Apr.

Abstract

Background: Cocaine abuse and dependence continue to be widespread. Currently, there are no pharmacotherapies shown to be effective in the treatment of cocaine dependence.

Methods: A 33-week outpatient clinical trial of fluoxetine (60 mg/day, po) for cocaine dependence that incorporated abstinence-contingent voucher incentives was conducted. Participants (N = 145) were both cocaine and opioid dependent and treated with methadone. A stratified randomization procedure assigned subjects to one of four conditions: fluoxetine plus voucher incentives (FV), placebo plus voucher incentives (PV), fluoxetine without vouchers (F), and placebo without vouchers (P). Dosing of fluoxetine/placebo was double blind. Primary outcomes were treatment retention and cocaine use based on thrice-weekly urine testing.

Results: The PV group had the longest treatment retention (M = 165 days) and lowest probability of cocaine use. The adjusted predicted probabilities of cocaine use were 65% in the P group, 60% in the F group, 56% in the FV group, and 31% in the PV group.

Conclusions: Fluoxetine was not efficacious in reducing cocaine use in patients dually dependent on cocaine and opioids.

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Conflict of interest statement

Conflicts of Interest: The authors report no conflicts of interest relevant to this study.

Figures

Figure 1
Figure 1. Study Phases
Figure 2
Figure 2. Study Profile
Figure 3
Figure 3. Kaplan-Meier Survival Estimates of Treatment Retention by Treatment Group in the ITT Sample (n=145)
Note: Survival was defined as remaining in treatment through the end of week 18.
Figure 4
Figure 4. Comparison of Predicated Probabilities of Cocaine Use Comparing Qualitative Urine Toxicology, Quantitative Urine Toxicology, and Self-Reports by Treatment Group

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